What Is Xarelto?
Xarelto is an anticoagulant (blood thinner) drug often used to prevent and treat certain types of blood clots, typically after lower-body joint replacement surgery, but it has also been prescribed for people with atrial fibrillation. Developed and marketed by Janssen, a wholly owned subsidiary of Johnson & Johnson, Xarelto is the second-most used anticoagulant drug in the United States.
Rivaroxaban, the active ingredient in Xarelto, works by inhibiting factor Xa, an enzyme that facilitates the blood coagulation process. One of the big advantages of Xarelto and other direct factor Xa inhibitors is that they work very quickly, whereas other blood-thinners like warfarin take longer to work because they indirectly affect the blood-clotting process.
However, unlike warfarin, there is no antidote to reverse the effects of rivaroxaban. This means that patients who are severely injured while taking Xarelto have a high risk of bleeding to death, since their blood will not clot.
Xarelto Side Effects and Adverse Reactions
Because of the severity of Xarelto side effects, and since there is no antidote, even minor cuts can become dangerous and even life threatening. It can take a long time for bleeding to stop, and it may be easier to bruise while taking the drug.
Xarelto Antidote Still in Development
Some blood thinners have antidotes to reverse its side effects in the event that a patient cannot stop bleeding. For example, the anticoagulant warfarin can be counteracted by the patient taking vitamin K. However, Xarelto (rivaroxaban) is in a class of drugs known as factor Xa inhibitors, for which no antidote currently exists.
In 2016, a drug called Andexxa developed by Portola Pharmaceuticals was rejected by the U.S. Food & Drug Administration as a potential Xarelto antidote. Portola claimed that the drug is effective at reversing the anticoagulant effects of rivaroxaban and similar drugs based on two studies published in The New England Journal of Medicine. However, the FDA rejected the company’s claims, saying it wanted to know more about the drug’s manufacturing process and labeling information before approving the antidote.
Xarelto Drug Interactions
Before you begin taking a new drug, it’s important to know how it will interact with any current medications or supplements you may take. Any drugs, vitamins and supplements that have blood-thinning effects should be avoided while using Xarelto. Even OTC medication such as aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) can pose a risk when taken with a blood thinner.
The drug’s medication guidelines warn patients to tell their doctors if they are taking any of the following medications or supplements in addition to Xarelto.
Xarelto Drug Interactions
Xarelto Deaths and Injuries
Bayer and Johnson & Johnson, the two companies who developed and marketed Xarelto, are defendants of a number of cases due to serious bleeding that has disabled and even lead to the deaths of a number of people who took the anticoagulant.
One such case was brought by Joseph Boudreaux, a part-time security guard who lives in Louisiana. Boudreaux had been prescribed Xarelto by his cardiologist to reduce the risk of a stroke after experiencing atrial fibrillation. After taking the medication as prescribed, however, he spent a week in the intensive care unit at the hospital due to severe bleeding in his gastrointestinal system.
While Boudreaux survived his ordeal, Xarelto has been linked to at least 370 deaths. Tens of thousands of other individuals believe that the drug has caused their bleeding problems as well, many which have brought suits against the companies responsible.
Xarelto Uses & Medical Information
In 2011, Xarelto was initially approved by the U.S. Food & Drug Administration (FDA) to prevent venous thromboembolism (VTE) – that is, blood clots – specifically after knee or hip replacement surgery. Lower-body joint surgeries are especially prone to developing blood clots during recovery, which can lead to health problems like stroke or even death.
Xarelto Drug Details
Blood clots, deep vein thrombosis (DVT), traveling blood clots (systemic embolism), pulmonary embolism (PE), stroke
Janssen Pharmaceuticals (subsidiary of Johnson & Johnson)
10 mg, 15 mg, 20 mg
Approved in July 2011; label updated in August 2016
Xarelto works by preventing an enzyme called factor Xa, which is a critical component of the series of biological responses that cause clotting. Xarelto works for both extrinsic injuries, such as cuts and abrasions, as well as intrinsic injuries like cardiovascular problems or strokes.
Note that anticoagulants like Xarelto, warfarin, and similar drugs, are a different class of blood thinners than antiplatelet drugs like aspirin. Antiplatelets prevent platelets from aggregating, whereas anticoagulants prevent blood clotting by inhibiting factors after platelet aggregation occurs.
Other Approved Xarelto Uses
Since the original approval, the FDA has approved Xarelto to treat two other conditions. The first of these is to reduce the risk of traveling blood clots (called systemic embolism) and stroke in individuals who have been diagnosed with nonvalvular atrial fibrillation, a rapid and irregular heart rate that causes poor blood flow.
The other FDA-approved use is the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE). Deep vein thrombosis typically occurs in the large veins of the legs, and can develop especially after surgery or in people who lead sedentary lifestyles. Certain medical conditions and diseases can also increase the risk of developing DVT. If the thrombosis (blood clot) gets big enough, it can break off and travel through the body, often getting caught in the lungs, where it becomes a pulmonary embolism. Pulmonary embolisms are serious medical conditions that can lead to trouble breathing, chest pain, and even death if left untreated.
Xarelto Clinical Trials
The first Phase III study of rivaroxaban to treat atrial fibrillation is known as ROCKET AF. Conducted between 2006 and 2010 by Johnson & Johnson Pharmaceutical Research & Development with collaboration from Bayer, the ROCKET AF trial was the primary source of evidence that the FDA relied on to approve the use of Xarelto.
In recent years, the ROCKET AF trial has come under fire by scientists who found fault with the conclusions of the study authors. Further controversy was raised when it was discovered that equipment malfunctions occurred during the study, potentially compromising Xarelto trial results. Scientists from Duke University published a paper in the New England Journal of Medicine concluding that the faulty devices did not impair the study, but that paper itself was funded by Johnson & Johnson and Bayer, both of whom had previously kept silent about the defective instruments used during ROCKET AF.
Since then, Xarelto has continued to undergo trials to monitor its effectiveness against other blood thinners such as warfarin (Coumadin and Jantoven), aspirin, apixaban (Eliquis) and dabigatran (Pradaxa). In general, these studies have been inconclusive about the overall safety of Xarelto in comparison to other drugs. For example, one study published in September 2016 concluded that warfarin, rivaroxaban, and dabigatran all have similar bleeding rates. However, a study published in November 2016 indicated that rivaroxaban is associated with “statistically significant increases” in both intracranial bleeding (i.e., bleeding in the brain) and bleeding elsewhere in the body, including gastrointestinal bleeding.
Because there is no antidote for Xarelto, many thousands of people have experienced severe internal bleeding that can cause other medical problems or even lead to the patient’s death. As a result, thousands of lawsuits have been filed by patients who have been injured while taking the drug (or their surviving family members in cases where the patient died).
Those who file a Xarelto lawsuit because of problems with the drug are often looking to recover medical expenses, reclaim lost income, and punish Janssen and Johnson & Johnson for failing to warn them about problems with the blood thinner. In the most recent verdict, a couple was awarded $28 million after severe bleeding complications related to the drug.